Editorials

April 03, 2013

Doctor collaborates with industry to conduct lifesaving, breakthrough research.” “Doctor educates colleagues about safety and clinical date to improve patient outcomes.” “Physician speaks to peers about new trials that improve patient access to needed drugs.” “Researchers meet to ensure the success of new clinical trial.”

“Physician invents new medical device that improves cardiovascular health.” “Industry and physicians collaborate to bring drug to market faster through new approval pathway.” “Physicians attend education program mandated by FDA under REMS to better understand benefits and risk of drugs.”

Of all these headlines, few, if any, are ever chosen by mainstream or local media to describe physician-industry relationships and collaboration that produce longer, healthier lives for all Americans. In fact, the American Association for Cancer Research (AACR) recently released its second Annual Report on Cancer Survivorship, which showed that 18 million cancer survivors are expected by 2022.

The headlines describing this report, however, failed to recognize that such increased survival rates are influenced significantly by the breakthrough drugs, therapies and treatments pharmaceutical manufacturers have researched, developed and discovered over the past few decades. As Time Magazine noted, “advances in early detection and treatment are also contributing to helping people are live longer after diagnosis.”

Consequently, news outlets are continuing their misleading headlines and stories regarding physician-industry collaboration over the last few weeks by relying on the recently updated payment data posted by ProPublica and its Dollars for Docs campaign. This is particularly troublesome given that such news outlets will be able to significantly enhance the number of improper headlines once all payments are made public in March 2014 under the Physician Payment Sunshine Act. Arnold & Porter, LLP recently hosted a webinar to discuss the final rule and its implications for all stakeholders.

Charles Ornstein, who leads the Dollars for Docs campaign, told Medical, Marketing and Media in an interview that “companies’ strategies vary with respect to promotional speaking” in the latest update. For example, “Forest Labs, which is the 20th-largest pharmaceutical company based on 2011 US sales, spent more money on physician speakers in the first three quarters of 2012 than any of its peers (many of which are much larger).”

Ornstein recognized that trends are hard to determine given the different stages of brand lifecycles, which play a large role in terms of spending on speakers and marketing/sales. Ornstein noted that he did not see much change in doctor’s willingness to speak with reporters about such payments. Given the implementation of the Sunshine Act, Orenstein said that Dollars for Docs will still have a role, and provides unique aspects, such as linking to information about each drug on NIH websites.

“Beyond that, on every payment page, [Pro Publica] has created a checklist that patient’s can print out and bring with them to their physician visits if they would like to ask questions about the payments or the drugs they are being prescribed.”

Finally, Orenstein noted that ProPublica will be updating the database “from time to time,” and that it will be updated soon to include three new companies: Boehringer-Ingelheim, Sanofi-Aventis and Amgen. The site will also offer historical value for payments reported prior to the Sunshine Act collection start date of August 1, 2013.

Below is a summary of several articles, organized by State, that local and regional news organizations published after using the Dollar for Docs Database. Most articles include a ProPublica badge and a Dollar for Docs function that lets readers search for doctor payments directly from the article.

Louisiana

The shrevporttimes.com reported that Louisiana doctors received $23 million from drug companies between 2009-2012, with more than 36,000 payments. Doctors in northwest Louisiana raked in at least $4 million in payments from drug and medical device manufacturers since 2009. While many support the move to make the medical industry more transparent, critics say the data lack context and in its current form do little more than scare patients.

“Doctors and companies are automatically guilty until proven innocent if you’re looking at this,” said U.S. Rep. John Fleming, R-Minden, which is one of the many reasons he voted against the act. Fleming, a licensed physician, said doctors may not stop at eliminating speaking engagements as guidelines increase and more documents are disclosed. The disclosures when taken out of context can make doctors appear unethical, and some doctors may decide to stop participating in trials or anything involving these companies, Fleming said. “Ultimately, it’s going to hinder innovation and research — research that benefits all of us,” Fleming said.

Shreveport psychiatrist J. Gary Booker tops the region’s list of doctors receiving the most — $704,642 for research and meals. Booker emailed the Times saying that the data and figures only told “half the story.” “The studies pay well, but they are expensive to do,” Booker said. Booker said he has performed nearly 100 clinical trials over the years, and the work he is doing could translate to long-term benefits for patients. For example, he cited a recent study in which he worked to remove a plaque associated with Alzheimer’s disease from the brain.

Robert Marier, executive director of the Louisiana State Board of Medical Examiners, said doctors across the state are participating in cutting-edge research funded by these drugs, and protocols are in place to ensure doctors are behaving ethically. “When you hear your doctor or any doctor is receiving funds from these companies, it can raise a red flag, but there are so much oversight from institutions, like medical centers, as well as the state and federal regulations,” Marier said.

At LSU Health Sciences Center in Shreveport, Dr. John Vanchiere collected at least $241,000 for research and speaking engagements from Merck and GlaxoSmithKline. However, Vanchiere, chief of pediatric infectious diseases and vice chair for pediatric research, said the majority of that money went to LSU Health for a clinical trial — not into his pocket.

“That’s why a lot of people are not happy with these disclosures, and these numbers can quickly be misinterpreted and taken out of context,” Vanchiere said—the final Sunshine rule may resolve this issue. The trial, funded by Merck, is an effort to limit the number of required childhood immunizations while maintaining effectiveness in preventing disease. Instead of a series of vaccines, as little as two could be required, he said. “These studies have the ability to impact patients’ lives,” Vanchiere said.

Maine

The Portland Press Herald reported that payments to doctors in Maine between 2010 and 2012 dropped by 60%. Money paid to doctors in Maine for research, usually clinical drug trials, increased by 40 percent from 2011 to 2012 ($450,390 to $788,755). The database includes 927 total disclosures in Maine from 2009 to 2012. Merck spent the most on research, followed closely by Pfizer.

Eli Lilly spent the most money in Maine by far on speaking engagements, paying $571,572 for 37 appearances. GlaxoSmithKline paid for 50 speaking engagements in Maine during that time and spent $256,262.

In the top right of the article is a photograph of Dr. Jeffrey Barkin, who received $114,225 from drugmakers between 2009 and 2010. Dr. Barkin maintained that he never felt his speaking engagements were a quid pro quo arrangement. “I wasn’t writing more prescriptions for those drugs,” he said.

Gordon Smith, executive director of the Maine Medical Association, noted that while companies used to reward doctors with perks, “those days are gone … largely because the American Medical Association updated its code of ethics and because of the increasing number of disclosures by the companies.”

Below that picture, the Herald posts a snap shot of “Maine doctors paid the most by drug companies for speaking engagements from 2009-2012,” with a top 10 list. Below, is a top 10 list for Maine doctors paid most by companies for research for the same period. In addition to the top 10 lists, the Herald also provides a look at some of the most commonly known drugs associated with leading pharma companies, such as Eli Lilly, Pfizer, Merck, and GSK.

Dr. Robert Weiss, an Auburn cardiologist, received $407,498, the highest total amount for research funds between 2009 and 2012. Weiss, a nationally respected cardiologist, said he was often asked by drug companies to speak about a specific drug or course of treatment. In most cases, he said, he agreed to the request because he had free rein to talk about both the benefits and drawbacks of the drugs.

The Herald, however, included a discussion of companies having to review slides or asking doctors to speak from scripts—trying to suggest influence. However, the Herald failed to recognize that such slides must be reviewed by the company to ensure compliance with FDA regulations and that such procedures are mandated by FDA.

Already demonstrating the negative impact of increased transparency, Weiss said that some of his colleagues have stopped taking clinical research funds because of the increased scrutiny brought on by disclosure. Weiss, who has been doing research for 30 years, said that almost all the money he has received from drug companies has gone to pay his 19 employees and cover stipends for patients who participate in the trials.

There was some debate in the article about whether drug research is conducted properly or clinical trial data is accurate. Weiss, however, pointed out that he has never been pressured to approve a drug, and most never even reach the market, which is part of the reason drugs cost so much.

Barkin told the Press Herald that his speaking engagements were never specifically tied to certain drugs. Rather, his talks were about educating other physicians on appropriate diagnoses for psychiatric disorders and about the overlap of physical disease with psychiatric disease and how that can sometimes lead to fragmented care.

Scott MacGregor, communications director for Lilly USA, the domestic arm of Eli Lilly, said that employing experts to lead educational forums is a critical part of drug development. He said payments are largely market-driven, depending on the development stage of a particular drug.

The Herald claims that the most common payment, for travel and meals, represents about 60 percent of disclosures, “and it is given when a drug company pays physicians to listen to a presentation about a product.” It is unclear how the Herald made this determination that all such travel/meals are for product education or promotion, rather than for investigator or research meetings.

Missouri

Using the biased headline of “Drug Money: How Pharmaceuticals Earn A Doctor’s Endorsement, KMOX news radio in St. Louis noted that hundreds of doctors received payments for speaking fees, travel and meals. Without providing any context for such payments or the importance of physician-industry collaboration, the article dives into listing several high-paid physicians who work at Washington University in St. Louis. Later, the article lists payments to several psychiatrists in St. Louis, pointing out that such physicians are paid the most across the country.

KMOX News reached out to several of these physicians. Joni Westerhouse, spokersperson for Wash. Univ. School of Medicine, explained that Dr. Jeffrey Gordon, does not see patients or prescribe drugs. Dr. Brian Dieckgraefe does prescribe drugs, including those made by Pfizer, but, according to Westerhouse, fully discloses to patients his financial ties to the company before doing so.

Nevertheless, the article fails to elaborate on the nature or context of payments, or even mention that such fees are almost always fair market value and go towards educating other doctors about new safety and clinical data, all of which improve patient outcomes and may even reduce healthcare costs.

Susan Chimonas, a research scholar at the Columbia University Center on Medicine as a Profession who has been studying these relationships, expressed her concern with some interactions, but recognized that some relationships are “beneficial for physicians, and therefore, for their patients.” Nevertheless, Chimonas—and the article—dedicate their comments on how such relationships are negative, and paint a picture of the old habits that companies used to engage in. Those practices are long gone, prohibited under industry codes and strongly prohibited by corporate integrity agreements (CIAs) and other settlement documents between most of the companies and the federal government.

The article pointed out that the Washington University School of Medicine first revised its conflict-of-interest guidelines in 2007. The policy prohibits doctors from using promotional items such as pens and magnets in clinical areas and says “meals, sporting event tickets, golf outings, gift baskets, travel, and any other free goods or services” should not be accepted from industry vendors. The changes also ensure speakers “have final editorial discretion as to lecture content and materials,” however, this must be balanced against FDA’s requirements.

At the time of the change, four companies – Pfizer, Bristol-Myers Squib, AstraZeneca, and Sanofi-Aventis – refused to comply with Washington University’s new policy. Dr. James P. Crane, executive vice chancellor for clinical affairs in the School of Medicine, then advised his faculty to cut ties with the companies. Some of those companies later agreed to comply with the university’s requirements, according to Washington University School of Medicine spokesperson Joni Westerhouse.

Pennsylvania

The yorkdispatch.com, in York, Pennsylvania, reported 160 instances in which York-area physicians or medical facilities received payments from pharmaceutical companies. Of those, 50 of the payments were for more than $1,000—are we really wasting our time being concerned with $1,000? It probably costs most companies and government agencies over $1,000 to track and report such payments!

Dr. Wanda Filer, a family medicine physician at Family First Health, was paid by Merck for traveling across the United States giving educational vaccine lectures to medical staff, she said. “It wasn’t for prescribing anything, …It was for travel costs.” Filer’s lectures were mostly about Gardisil, an HPV vaccine. As a result of the lectures, she said, she helped incorporate new public health guidelines in practices nationwide, as “a lot of people were not up-to-date on their guidelines.” She no longer speaks because she was elected to the board of directors of the American Academy of Family Physicians and didn't want a conflict of interest.

Dr. Kevin McCullum, a cardiologist at Cardiac Diagnostic Associates, is listed at the top of the database for York doctors with an $84,615 payment from Merck for research. But he said the money actually went to York Hospital, not his bank account. Dr. McCullum said the U.S. government funds almost no research, so his clinical research on preventive drugs is paid by pharmaceutical companies because his team looks almost exclusively at new drugs.

McCullum said he keeps the patient’s needs and the cost of medicine in mind when prescribing to patients, prescribing drugs that correlate to the individual's clinical condition and recommending cost-effective medicine when he can and takes the results of his research into account. McCullum said he is doubtful about the possibility of these payments being used for unethical purposes -- like doctors partnering with a drug company and getting paid to promote its product.

“First and foremost, I don't think it happens, … [a]nd I can assure you that here in the WellSpan Health system, that doesn’t go on.” He said there are layers and layers of safeguards in place when it comes to clinical research, such as performing double-blind trials, where both patient and researcher are unaware if drugs or placebos are being administered. “All (the safeguards in place) are acting as advocates to the patient,” he said. “The cost is so high because there is so much work involved.”

Massachusetts

The lowellsun.com reported that more than $97 million has been paid to physicians in Massachusetts by pharmaceutical companies between 2009 and 2012, including $1.5 million to Greater Lowell physicians. Lowell General Hospital spokeswoman Angela Strunk said physicians employed by the hospital must disclose any relationships to pharmaceutical companies, according to their contracts. Payments to Fitchburg, Leominster, Lancaster and Gardner-based physicians totaled $585,000, according to data released by pharmaceutical companies and collected by ProPublica.

We recently reported that Massachusetts posted its annual payments for 2011, showing a 3% decrease.

Partners HealthCare, the parent organization of Massachusetts General and Brigham and Women’s hospitals in Boston, prohibited doctors from participating in promotional drug company speakers bureaus as of January 2010, concerned that physicians could lose their objectivity.

Dr. Andrew G. Kowal, an anesthesiologist at Lahey Hospital and Medical Center in Burlington, has earned $337,651 from Pfizer and Eli Lilly for speaking, consulting, meals and travel fees from 2009 to 2011. In an interview with The Boston Globe, Kowal, a critic of the overuse of addictive opiates, said he talks about alternative treatments such as Pfizer’s Lyrica for fibromyalgia. At the time, he vowed to continue speaking free of charge, but he has not collected any payments since 2011, according to ProPublica’s data.

Lahey CEO Howard Grant told the newspaper last year Kowal did not violate hospital policy in speaking at Pfizer events because he discussed only fibromyalgia and not a specific drug. The hospital’s consulting policy states physicians may accept compensation for providing consulting services under certain circumstances.

Lahey’s policy states that a physician is prohibited from participating in talks where the company has a contractual right to control what the doctor says, creates the presentation materials or approves content or controls the publicity related to the event.

Physicians are also banned from participating in industry-sponsored speakers bureaus for which the doctor receives compensation to act as the company’s spokesperson to disseminate company-generated materials or to promote company products. Doctors who serve as consultants for industry must submit a conflict-of-interest form that discloses the expected compensation.

In another article covering the same area, the SentinelandEnterprise.com noted that Dr. Lawrence DuBuske, an allergy and immunology specialist earned more than $688,601 from pharmaceutical companies AstraZeneca, GlaxoSmithKline, Merck and Novartis between 2009-2012. We noted several years ago that DuBuske had protested new policies banning relationships with industry and resigned from Brigham and Women’s Hospital in Boston. DuBuske has courtesy privileges at Heywood Hospital in Gardner, which requires physicians to disclose any conflict of interest as it pertains to pharmaceutical companies, medical device companies or other organizations when appropriate.

HealthAlliance Hospital in Fitchburg, which is partnered with the University of Massachusetts Medical School, has a compliance policy regarding business transactions or arrangements with persons of interest in order to mitigate conflict of interest, according to a hospital spokeswoman Mary Lourdes Burke. Burke said none of the hospital’s physicians are part of the data collected by ProPublica.

March 02, 2012

Now that the comment period for the Physician Payment Sunshine Act (Section 6002 of the Affordable Care Act) has closed, various news media have begun discussing and examining the potential impact this legislation and regulations will have on healthcare stakeholders.

Unfortunately, these media have decided to focus on selling stories and headlines about “potential conflicts of interest,” instead of telling the true and balanced story behind physician-industry collaboration. For example, a recent editorial from an unnamed author in USA Today, claimed—without providing any evidence (since none exists)—that “small-bore favors such as free samples, promotional trinkets, tickets to sporting events, and deli trays delivered to the office have evolved into practices that look more like outright bribes.”

These kinds of claims are outright wrong and unethical. They are nothing more than smoke and mirrors to promote an anti-industry agenda to support some peoples academic careers and livelihoods.

The reality is, the kind of practices described above are practically non-existent, illegal, and banned by PhRMA and AdvaMed codes. In fact, the USA Today article’s only mention of evidence of this activity came from a 2007 article. And that article itself likely collected data from prior years. So in its duty to report fair and balanced information, the USA Today failed by using old data and not even attempting to discuss the current state of industry.

The article claims that while “the drug industry stopped paying for some restaurant meals and distributing trivial gifts such as mugs, pens and the like,” items like vacations thinly disguised as educational seminars and fees — kept flowing. But this is absolutely incorrect. ACCME and AMA rules ban such meetings for accredited educational programs, and while promotional programs may still exist, these have been restricted severely as well. The “good old days,” as the author would like to believe still exist, are long gone.

Consequently, the article then moves on to discuss the Physician Payment Sunshine Act, which requires pharmaceutical and medical device manufacturers to report and submit all payments they make over $10 to physicians and teaching hospitals. The author’s viewpoint is that, “Physicians and medical schools are still fighting to limit the law's reach.”

The article notes that, “Doctors insist that industry payments lead to valuable innovations, not to conflicts of interest.” And the author admits that this is “sometimes true.” But instead of delving into the lifesaving breakthroughs, treatments, and technologies that have come from physician-industry collaboration, the article and author does what mainstream media do best: dramatize reality to sell papers and sensationalize news, leaving the hardworking physicians and patients to suffer from their publishing and editorial greed.

The article references “investigations” that have “turned up evidence of payments that could compromise patient care, drive up medical costs and weaken drug safety.”

We do not condone the past behaviors of companies, executives, or employees who have engaged in deceptive, immoral and unethical behaviors. Those individuals and parties who have defrauded our government and harmed patients deserve to be prosecuted to the fullest extent the law allows. These investigations, however, are rare instances, and involve a tremendously small amount of individuals.

The overwhelming majority of individual physicians who are consulting, researching, and educating physicians are ethical physicians. They would not deceive or harm patients for a pen or pizza or for that matter $10,000. These physicians, as we have quoted many times, work with industry to advance medicine, to teach their peers, to interact and learn from other experts, and to ensure better patient care.

However, USA Today could care less about the lifesaving treatments and medical devices that industry and physicians are creating every day. The author sensationalizes and stigmatizes physician-industry collaboration without even considering or mentioning the value these relationships provide. There is no mention of how American lifespan has increased tremendously, how cancer and heart disease death rates have dropped significantly, and how medicines and treatments are reducing the incidence and costs of chronic diseases such as diabetes, hypertension, and asthma.

The only thing the author even says is the following: “some paid collaborations between doctors and industry yield important medical discoveries.” Hardly a journalistic attempt considering the significant emphasis and research the author put on the opposing view.

Instead, the article focuses on the few cases where investigations have showed that the proper firewalls and safeguards were not used or in place, which allowed the “potential for conflict” to appear.

Opposing View

Lance K. Stell offered the opposing view to the above editorial. Of course, USA Today gave Stell half as many words to respond to the “majority view” noted above.

Dr. Stell, who teaches medical ethics at Davidson College and at Carolinas Medical Center, noted that, Supporters of the Physician Payments Sunshine Act fail to take into account how expensive sunshine" would be. He recognized how, “Requiring drug and medical device manufacturers to publicly report virtually every payment they make to physicians, physician groups and teaching hospitals will end up costing far more than the $224 million estimated for just the first year of compliance.”

As Stell noted, however, “The biggest cost will be the valuable, socially useful physician-industry collaborations that simply won't occur.”

In 2007, the measure's original sponsors, Sens. Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., argued that shedding light on industry payments to physicians would be good for the system. The Pew Prescription Project, alarmed by findings that more than 90% of physicians receive payments of some kind from the pharmaceutical industry, opined that patients deserve to know whether their doctors are on the take.

“Sunshine supporters always affirm that many financial relationships between medicine and industry are necessary and beneficial. However, the measure's title implies that such relationships need detoxification by exposure to "sunshine," the best disinfectant.”

Stell asserted that, “The new law stigmatizes payments and deters accepting them. But it's utopian to suppose that doctors will give their time and effort for free to do socially useful research and peer education.” In fact, many physicians won't want to be enshrined in this hall of shame.

Instead, Sunshine will just make physicians “require higher payments to provide what even "sunshine" supporters agree is valuable work. How much higher? That depends on how our most talented and innovative physicians price their time and how much compensation they'll charge for loss of anonymity and insinuations of corruption that a sunshine listing implies.”

Ultimately, Stell noted that supporters of the Sunshine Act “foresee only benefit devoid of risk. But they've done no credible cost/benefit estimate. Reporting errors, misattribution and mistaken shaming will occur.”

What is most problematic about this, as Stell points out, “the government candidly acknowledges that it has no empirical basis for estimating the frequency of improper payments, the likelihood that reporting will reduce them, or the likely effects on reducing the costs of medical care.”

Conclusion

As CMS begins going through the hundreds of comments stakeholders submitted on the proposed Sunshine regulations, the media will continue to press on about the potential impact of publishing physician payments. It is important to remember in reading articles about physician-industry collaboration that many of the articles and journalists covering these topics will only take the viewpoint that industry is bad and payments for collaboration are inherently wrong.

We encourage readers to do their own research, to ask their own doctors and healthcare providers about the important value industry provides to them, whether through education, research, new products and treatments, and grants. While transparency and sunshine is important for patients and consumers, it is also important to know the context of these relationships and payments. Patients should be skeptical about reading articles that stigmatize a few bad apples to generalize an entire profession of healthcare providers who are overwhelming ethical and practice medicine to improve patient health and advance science.

March 12, 2010

Recent evaluations of professional societies and accredited continuing medical education (CME) providers have “further questioned the legitimacy of industry physicians and biomedical scientists providing scientific information or participating in educational program planning.” These evaluations have “deemed that such participation is in violation of ACCME guidelines,” according to a recent article in Clinical Pharmacology & Therapeutics titled Continuing Education Reform: Are We Throwing the Baby Out With the Bathwater?

Specifically, the article looked at the practices of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), who underwent a CME review in 2009. As a result of that review, the Society will no longer be in a position to provide CME and continuing pharmacy education (CPE) after the 2010 Annual Meeting. Accordingly, the article goes on to explain why such a decision was made, and how it affects the overall understanding of continuing education (CE).

Continuing Education

As we have written many times, CE or CME “is the process by which health professionals keep current with the latest knowledge and advances in health care.” Without CME, doctors and patients would continue to suffer from old and new diseases and symptoms, and be forced to choose outdated treatments, devices and medicines to help with their disorders and illnesses. Over the past few decades, the collaboration of industry and physicians who provide CME has resulted in numerous breakthroughs in patient care. Despite the obvious benefits gained from these relationships, the claim that “there are major flaws in the way CEis conducted, financed, regulated, andevaluated” raises serious concerns.

Such a claim is misguided, and to suggest that the numerous providers, researchers, physicians and accredited CME providers are “not optimally prepared toprovide the highest quality of care topatients or to meet public expectationsfor quality and safety” is problematic.

As the authors trace the history of CME, they note its importance for addressing the issue of improperly trained practitioners (prior to World War I), and its use for helping well-trained physicians keep current with advancing knowledge (after World War II). It was shortly after this time that the pharmaceutical industry became involved with CME, and “professional product representatives were an important resource for providing physicians with new information.” Consequently, the present “construct of using CME to improve performance began in the late 1970s, when CME was suggested to be a continuous process based in practice settings.”

Over the years, criticism has gained momentum about the interactions industry has with CME, and as a result, a process of regulation “began largely as a method for the American Medical Association and state medical societies to monitor the pharmaceutical industry’s influence on physician education.” Another result from this regulation was that “CME increasingly became provided by a combination of specialty societies, state and local medical organizations, and pharmaceutical companies,” and not just one singular source.

In the arena of continuing pharmacy education (CPE), the landscape is a bit different, with “approximately 43% of CE programs for pharmacists receiving commercial support.” Such “high levels of support” have resulted in some to assert that CPE “are dependent on industry to assist them in covering administrative, educational, and non-educational expenses.” As a result, the “most recent iteration of these regulations from the Accreditation Council for Pharmacy Education assert that “the provider must plan all CPE activities independent of commercial interest.”

The result of such regulations have “systematically stripped CE programs of content that is necessary to ensure education and performance improvement of practitioners.” Consequently, CE programs have also suffered from these kinds of regulations because their goals have “been grossly misplaced such that the passive participation of professionals who must demonstrate evidence of CE to maintain certification/licensure is fostered more than the actual delivery of information amenable to translation into working knowledge.”

Industry Support

Criticisms that industry support biases or conflicts CME programs are unwarranted because the current CME “system has integrated sources of financial support, accreditation mechanisms, and CE methods in such a way that it is nearly impossible to analyze any of them independently.” In other words, critics cannot just point the fingers at industry because “CE funding comes from numerous sources.”

For example, “health professionals themselves, employers, commercial entities, and, to a much smaller extent, the government” all fund CE programs. “In 2007, physicians paid 42% ($1.05 billion) of the total $2.54 billion spent on CME, which resulted in approximately $1,400 per year of out-of-pocket costs per physician.” Such investments prove how “many organizations and employers see CE as an important investment in staff development and thus provide financial support for at least a portion of CE costs.”

What critics and opponents are not happy with is the reality of a glooming economy over the past year or two, and an economic crisis that saw rapidly “shrinking resources and increasing costs associated with both providing and obtaining CE credits.” As a result, while the need for CME only continues to grow as more patients fill our hospitals and more diseases are found, “continuing professional education within the health-care arena is quickly becoming a non-sustainable venture.” So then, as the authors ask: what could happen if commercial funding was totally withdrawn and no subsidies were provided by other sources?

On average, physicians would have to invest approximately $3,500 annually to continue to attend the same types of CME activities that are currently offered, with similar figures for nurses, pharmacists, etc. Of course these numbers don’t account for travel, lodging, and other associated expenses.

Potential for Conflict

Just because there is a “potential for conflict” does not mean there are conflicts within industry funded CME. Although countless efforts to develop safeguards meant to ensure that CME providers are free from conflicts of interest have been developed, “widespread skepticism remains about the intentions of entities that provide CME.”

This kind of worrying is misguided because CME providers need to “appropriately support the real costs (e.g., travel and lodging expenses, modest honoraria to compensate for effort in developing content of CE presentation) associated with the development of unbiased, high-quality CE.” Supporting these legitimate and legal costs is essential for medical education and pharmaceutical companies to “be able to retain the services of true experts capable of providing current and credible educational programs.”

Accordingly, “the considerable progress that has been made in the past 5 years toward protecting educational content from potentially corrupting influences and promotional intent, rigid, industry-wide adherence to current guidelines can eliminate commercial bias.” Examples of these protections include detailed regulations from ACCME to “ensure that commercial well interests are kept separate from learning activities and course content.”

“The regulations require CME providers to disclose conflicts of interest and resolve relevant financial relationships with any commercial interest among those in a position to control CME content. They also require that CME providers give a balanced view of therapeutic options and, with respect to education in clinical pharmacology and therapeutics, that any description of off-label drug use be disclosed as such, and that use of proprietary (trade) names for drugs be avoided.” These example clearly demonstrate that eliminating industry support is and overreaction, and would only hurt patients and doctors.

Moreover, the process for CME providers to become accredited also eliminates the potential for bias and conflict significantly because companies must be evaluated annually by the accrediting body with associated annual fees that increase each year. This “institution of processes enables continuous quality improvement (most of which introduce progressively increasing allocation of resources to ensure compliance), and continuing contact between the accrediting body and providers.” In fact, both ACCME and the ACPE adopted new accreditation policies and standards that went into effect in January 2009. These new policies require that “no employees of a commercial interest can serve as planners or speakers in any accredited CME activities if the content relates to the “business lines and products of its employer.”

Conclusion

With a growing population, and increasing number of elderly and sick, America needs “a workforce of competent health professionals” that can use and learn the best health-care practices that effectively cure and prevent disease and promote well-being. In order to achieve this success, an “integrated system of CE is an important contributing factor to knowledge and performance deficiencies that occur at individual and systemic levels in the United States,” one which includes industry support.

Today, it’s not just about short-term profits because companies are “funding programs that have the most impact on physician performance.” This kind of industry support provides immense value for all involved. Any attempts to “ban industry contribution from CE in a manner that lacks insight and careful planning is sure to be detrimental to academic medicine and, ultimately, to patients.”

Ultimately, “discounting legitimate and high-quality science and not offering it as part of CE because it originates from industry is not necessarily a good plan with the potential of disastrous long-term consequences.

Likewise, to imply that scientist’s present biased material merely because they are employed by industry is inaccurate and ill thought out.” As the author of this article correctly asserts, “some of health care’s greatest contributions have originated from industry-sponsored science,” and to eliminate them now would be detrimental to patients.

March 09, 2010

An editorial in Natureused the recent appointment of William Chin as a perfect example of why “industry talent should be welcomed into academia, not seen as a corrupting influence.” Inhis new role as executive dean for research at Harvard Medical School, Dr. Chin, who was a top executive at the pharmaceutical giant Eli Lilly, will use his experience to create new treatments that will help numerous patients and help educate thousands of doctors.

Particularly interesting about Dr. Chin is that he spent 25 years at Harvard and its affiliated hospitals before moving to Eli Lilly 11 years ago. Critics believe that moving between companies and academia creates a conflict that taints the academic enterprise. Such opponents use the few examples that exist academic researchers' failed (mostly did not understand because of complex and different rules) to disclose their industry income.

As the editorial correctly asserts, such critics are misguided, and have “have conflated the very existence of industry–academia collaborations with failure to disclose those links.” In fact, critics need to be more mindful of the ongoing efforts of pharmaceutical companies, ACCME, and other health care providers who are constantly updating codes of ethics to increase transparency. As a result of such endeavors, those against industry and academic collaboration must abandon the view that “any and all cooperation between industry and academics is inherently suspect.”

Such a perspective “has created a poisonous atmosphere that has driven some young investigators to take up other careers,” which means less treatments and studies will be done that could help cure diseases today and in the future. One example the authors noted of such a stigmatized atmosphere took place last week, “Robert Califf, vice-chancellor for clinical research at Duke University Medical Center in Durham, North Carolina, told a conference at NIH headquarters in Bethesda, Maryland, about a recent meeting where the leaders of major academic medical centers were afraid to sit in the same room with industry leaders — with the goal of enhancing understanding and cooperation — for fear of an outcry either in Congress or the media.”

This kind of fear undermines the true value and significance of industry-academic collaboration: helping patients find new treatments through clinical studies, research and development. The reality is, appointments such as Dr. Chin’s and meetings with industry and academia “are not only appropriate, but essential for strengthening university research and for bridging the gap between lab and clinic — a gap that has bred a justifiable public impatience for cures at the advent of the century of biology.”

Like many physicians and researchers who have worked in/with industry and academia, Dr. Chin “has both a physician's appreciation of illness and an enviable scientific pedigree.” In fact, any significant, ethical or legal worries about his work with industry are nonexistent as “the chairs of the medical school's basic-science departments endorsed his hiring unanimously.”

The experience physicians like Dr. Chin gain allow researchers and physicians to find and connect laboratory discoveries to human disease. Discovering such connections gives doctors “the kind of management experience and insights into discovery and translation that can be got only in industry.” More importantly, having worked inside and with industry for so long, Dr. Chin and others with similar experience will use their knowledge “to inform their efforts to guide a medical school's scientific interactions with industry, in the drive to meet critical medical needs.”

To exclude people like Dr. Chin from working in academia would truly hurt patients, and physicians seeking highly needed training and experience with industry, and not just free lunches. In addition, Harvard is not the only example, as the University of California, San Francisco (UCSF), last year named Susan Desmond-Hellmann, previously president of product development at biotech company Genentech, as its chancellor. Using her experience over the past six months since taking over, UCSF announced last week “collaboration with Genentech aimed at generating small-molecule drug candidates, a step that has proven a major obstacle in drug discovery.”

Ultimately, critics “fail to understand that industry–academia cooperation is essential if we are to speed the medical progress that everyone seeks.” Evidence of this progress will likely be seen in the coming years from the works of Dr. Chin and Ms. Desmond-Hellmann.Accordingly, critics of such collaboration must reevaluate their oppositions to consider what society will benefit from more: less interaction and experience with industry or more partnerships, such as those that have led to reducing heart disease, increasing cancer survival rates, and fighting HIV.

There is a significant movement within the Continuing Medical Educational process to avoid any “bias information”. The recent Justice Department probe and Congressional investigations into the medical device industry has everyone (professional medical societies) running scared and overreacting. There is significant discussion of removing commercial funding from CME to eliminate any bias information. This, in my professional opinion, is an overreaction and will create more problems than it could possible solve.

Let’s look at a few facts that benefit our current system of education. The health Care Industry supports educational activities to the tune of about one billion dollars ($1,000,000,000) a year within the United States (WSJ’s blog on health & the business of health 11/15/09). Our first assumption should be this is good because dollars are necessary to put effective teaching and learning tools into place. Imagine for a moment that we did not have this money available to education. How much longer would it take to train and educate our health care professionals? How many patients would suffer longer than necessary if our information on drugs, devices and techniques slowed down?

Who would pick up the financial slack, or would there just be a lag in training and education. The concern should not be that there is an industry supporting education, (thank God we have an industry that can help support educational activities) but focus should be on the process of disclosure not on elimination of funding sources.

I think we should be challenging our industries to increase their funding not looking at demonizing them because they do. We have with the Accreditation Council for Continuing Medical Education (ACCME® www.accme.org) procedures in place that are effective and do an adequate job with-regard to disclosure of commercial funding. These guidelines and standards need to be living documents that undergo their own review and modifications on an incremental schedule. Drastic or radical change is rarely beneficial.

It is time we challenged the proponents against “Bias Information” to back down and acknowledge all bias information is not bad. This is a term that is being misused and I for one look towards my selection of medical professionals to have strong biases within their practice of medicine. I just want them to disclose their biases.

Lets look at this term: bias

A term used to describe a tendency or preference towards a particular perspective, ideology or result.

The key is that bias information should be balanced with other or different perspective “Bias” information so there is a balance of information presented within the content of a given subject matter.

I suggest we all want to hear bias information because this information is often the result of training, experience and results. We don’t necessarily want to hear bias information that is based on monetary reward. However, often presentations and/or publications can have multiple biases within any given subject material. The proper way to inform individuals of “bias” information is through disclosure not by elimination. Only by disclosure can the audience determine if the quality of the information has true merit.

Just the fact of monetary interest does not suggest that the bias presentation does not have significant merit in its content, method and conclusions. The fact that there is a disclosure with regard to monetary benefit to the author should be considered and reviewed from that point of reference.

Example:A Total Hip Arthroplasty performed with the selection of femoral component being fully porous coated like the “AML® Stem”, suggest that the use of this device demonstrates a preference towards a device with extensive porous coating over the length of a cylinder style stem. Over the years, some surgeons that have lectured on their use of this stem have disclosed the fact that they had a financial interest in the device. This disclosure in no way changed the fact of the long-term clinical results, benefits and/or potential problems related to this device.

In my 39 years in the orthopaedic health care field I have never known any surgeon that has switched his selection of product and/or technique as a result of hearing one bias talk.

I have found just the opposite. Surgeons, because of their own biases due to their training and experience, are reluctant to change. They only change as a result of significant information that addresses a problem or concern they have experienced.

I am bias towards bias information remaining as part of our educational activities and I also continue to indorse the use of commercial funding for CME activities and wish the industry would increase its budget for balanced CME activities.

This is a subject that should be important to all of us involved with health care. Please feel free to contact us with your thoughts, JISRF welcomes all points of view.

They feature two Harvard Professors Marcia Angell-Relman, MD a former acting editor and chief at the New England Journal of Medicine who wants Harvard to adopt a policy of basically cutting all ties to drug makers. In her words doctors "should have no financial interest in companies whose products they are evaluating," she argues. No stocks. No money for speaking or writing for industry forums. Drug reps shouldn't be allowed on campus.

In combating her cut all ties approach is Thomas Stossel, MDa Harvard hematologist and brother of libertarian journalist John Stossel. When Angell wrote an op-ed in the Globe several months ago, Stossel promptly penned a rebuttal in Forbes. When Stossel was invited to speak at a 2007 public panel on pharma influence issues, Angell blasted the choice, saying that to include him amounted to "standing the whole thing on its head." The two are "matter and antimatter," says one acquaintance. "Put them in the same room and the universe might explode."

In fact, Angell and Stossel have been in the same room at least once. At what should have been a fairly dry meeting of the American Society of Hematology in 2002, they gave dueling talks. Angell spoke in broad terms about the "dissolving" boundaries between academia and industry; the fact that medical meetings had become "a massive trade show...with free goodies." Stossel got more personal. "I don't need to feel morally superior to drug companies," he said. "Let's object to sanctimony." Today, in person, he's even more barbed: When it comes to research credentials, he says, "I don't even consider myself in the same universe as Marcia Angell."

Like Angell, Stossel is well aware that Harvard physicians pull in a lot of money from drug companies. Unlike Angell, he sees that as a good thing. Stossel traces improvement in Americans' health directly to breakthroughs funded by the pharmaceutical industry. Limit doctors' interactions with that industry, he argues, and you limit the power of the market to drive innovation.

Stossel also argues that the various controversies concerning Harvard and Big Pharma are overblown. The Pfizer rep with the cell phone wasn't plotting a corporate takedown of the student protesters; he was taking photos of a public event out of personal interest. The professor who didn't reveal his links to cholesterol drugs wasn't technically doing anything wrong; Harvard only now requires that doctors disclose conflicts of interest in all public venues, including classrooms.

Stossel even refuses to condemn Biederman, the child psychiatrist, though he won't quite defend him, either. "The second you show me solid evidence that he should have backed off on some conclusion and didn't, he's toast," says Stossel. "But I bet what [the ongoing investigation] will find is that he didn't do anything wrong." Besides, he points out, having one bad apple among almost 10,000 faculty members is a risk worth taking. "We have to tolerate some bad behavior if we want progress," he says.

This past summer Stossel cofounded the Association of Clinical Researchers and Educators (ACRE), an advocacy group for doctor/drug company partnerships. It has been ruthlessly parodied—most notably as Academics Craving Reimbursement for Everything—but it has also attracted some followers, even among Harvard med students, some of whom say they're uncomfortable with the protesters' divisive stance. Angell's acolytes are "a vocal minority," says Vijay Yanamadala, a med student who sides with Stossel. "We all agree on more than we disagree."

This article outlines that Harvard is currently revising their conflict of interest policies but will not be cutting back on all ties to industry as some like Angell-Relman would like.

October 27, 2009

Today’s Milwaukee Journal Sentinel includes an editorial by Thomas Stossel, MD titled Doctor’s Presentations Helps Patients.The editorial is in response to a series of articles and editorials in the newspaper critical of physician industry collaboration.

Despite arguments to the contrary, doctors should be paid (Editorials, "Get off the gravy train," Oct. 7). They should be paid to bring specialized knowledge and experience to their patients. They also should be paid to bring specialized knowledge and experience to their colleagues.

Both exchanges create value and improve patient health. Hollow accusations should never obscure this fact. Promotional presentations by physicians should not be banned; they should be celebrated, for patients' sake.

Medicine, although rooted in science, is still an art. Ask any physician. And like every art, mastery comes from experience, not from simply reading manuals. Physicians are no different from other artists.

They need more than voluminous texts to practice their art. They need to hear from colleagues who have real-world experience with the medicines, devices and diagnostic tools that provide the foundation of modern medical care. Banning promotional presentations, where a presenter and the audience are allowed to engage in free and open dialogue about the benefits and risks of medical products, limits the opportunities to exchange these experiences.

The Journal Sentinel Editorial Board claims that when physicians promote products, "they risk their credibility with patients, risk clouding their judgment, risk overusing a treatment and risk driving up the cost of medicine." Everyone can agree that these risks do exist - nothing in life is without risk. The more important question, however, is whether these risks translate into harmful behaviors or consequences to patients? The resounding answer is no.

Polls repeatedly show that physician credibility is based on the care they provide, not the sources of information they access or how they educate their colleagues. Moreover, there is near consensus that non-financial factors such as gaining tenure, publishing and climbing the academic hierarchy are much more likely to prompt unethical behavior among academic physicians, who represent the majority of promotional speakers. These influences require much closer examination.

Of even greater importance, however, is how these activities affect patient care and patient health. Contrary to what critics would have us believe, under-treatment due to limitations in physician knowledge and experience is more detrimental to patient health and more likely to drive up costs.

Take diabetes as an example. The prevalence is skyrocketing, its causes and consequences are well understood and treatment options are many. Nonetheless, under-treatment is the rule, rather than the exception.

Although 71% of diabetic patients have high blood pressure, less than half get sufficient treatment to reach treatment targets. Failures such as these impart enormous costs on the quality of life, productivity and our nation's financial health. Severing physician interactions only contributes to these unnecessary costs.

The University of Wisconsin has a rich history of leadership in the medical field, and it has the opportunity to continue to lead. We hope it will foster a culture that values exchange of information and experience and puts patients back at their rightful place as the focus of medical policies.

Thomas P. Stossel, M.D., is ACRE co-founder and executive committee member, an American Cancer Society professor of medicine at Harvard Medical School, director of the Translational Medicine Division at Brigham & Women's Hospital. He is a founding scientist and director of Critical Biologics Corp. and a director of Velico Corp. He has contributed his views on physician-industry collaboration as a consultant to Merck, Pfizer, Amgen, Bristol-Myers Squibb and IMS Health.

·A 360-page report from the Institute of Medicine addressing "conflicts of interest in medical research, education and practice," all lead members to ask, "What is the position of the AAFP regarding interactions with pharmaceutical companies?"

The problems with these reports and opinions, according to the AAFP, are that they “start from a basic premise that any engagement with the pharmaceutical industry is a conflict and must be eliminated.”

Contrary to this belief, the AAFP does not accept this "good money/bad money" hypothesis, and neither do most professional associations because “pharmaceutical and other companies have a significant role to play in informing health care professionals about the availability and proper use of medications and other therapies.”

As “the nation's first recognized accreditor of CME the AAFP has an established membership and renewal criteria requiring accredited CME. In addition, “the AAFP has consistently demonstrated its dedication to supporting physicians in their obligation to learn and advance scientific knowledge by engaging in lifelong learning.” Consequently, after years of such experience, the AAFP, as do many professional associations know that “that potential conflicts of interest and relations with industry can and must be managed consistently and effectively.

Particularly, the AAFP feels that physicians and physicians-in-training have the responsibility to be trained in the appropriate use of medicine and devices when “industry's products are based on solid medical science and best clinical practices.” In order to manage these responsibilities, the AAFP has many policies in place to manage relationships between CME providers and funders, beginning with full disclosure. In fact, the Academy makes sure to prevent any potential conflict between content and funding and to resolve conflicts as needed.

As a result of such prevention for over 60 years, a study performed by the Accreditation Council for Continuing Medical Education, or ACCME, in 2007 demonstrated that there is no difference in the level of bias between pharmaceutical company-funded CME and nonfunded CME, as long as the CME is accredited according to the ACCME Standards for Commercial Support. Ways that the AAFP ensures transparency include:

·Training staff members to make sure conflict of interest forms for leaders and CME are standardized, consistent and clearly understood;

·Enhancing its faculty database reporting and searching functionality to prepare for organization-level reporting of faculty with industry relationships;

·Involving faculty and staff members in the AAFP CME educational National Faculty Education Initiative program offered by the Alliance for CME and the Society for Academic CME that clarifies the differences between promotional and educational activities; and

·Pursuing ways of incorporating patient, practice and clinical data into the needs assessment and outcome evaluation of AAFP-produced CME.

The AAFP also noted that it “does receive funds from pharmaceutical companies for an array of activities, from advertising in its journals to exhibits at the annual Scientific Assembly to grants for CME." According to AAFP, since these two categories do not apply, the AAFP's level of pharmaceutical industry funding is 11 percent, which is well below the "acceptable threshold" of 25 percent proposed by the authors of the JAMA article.

With over 94,000 members, the Academy, along with many other professional associations have a high degree of confidence in the ability doctors to know right from wrong and to refuse to let their professional judgment be influenced by trivial contacts that some individuals and government types now seek to criminalize. Trusting your doctor to make the best decisions for patients means getting the continuing medical education they need to stay up to date with new breakthroughs, research, clinical studies, medicine and devices.

As many CME supporters continue to ask: if industry support is lost or reduced, who will pay for continuing medical education?

The AAFP asserts that physicians will have to pay for CME if industry funding is removed. This is already a problem because doctors who need the education and individual learners or organizations, such as the AAFP, already pay more than 50 percent of CME costs. Without CME support, the “burden will shift even more” causing “added stress on family physicians in clinical practice” who cannot financially afford such programs.

If CME is less available to practicing physicians and more funds are shifted to promotional spending, such as direct-to-consumer ads, patients and providers will both suffer. Doctors need CME to learn about the medicines and treatments they use with their patients so they are prepared to effectively diseases they will encounter.

By taking a leading step in supporting industry-physician relationships, the AAFP has given a clear message that patients should support: the need for CME is only growing with the discovery of new treatments and medicines, and family physicians consider commercial support of CME a vital part in delivering quality patient care.

The Milwaukee Journal Sentinel has lauded its recent coverage of the continuing medical education program at the University of Wisconsin School of Medicine and Public Health (Editorials, Aug. 16). These articles may mislead readers into viewing our CME program as little more than a paid mouthpiece for commercial interests that seek to manipulate physicians.

Nothing could be further from the truth.

An objective, unbiased assessment confirms that the academic integrity of the UW School of Medicine and Public Health's Office of Continuing Professional Development is not in question. The Accreditation Council for Continuing Medical Education, the nonpartisan organization that sets and monitors the standards for CME programs across the country, recently completed an independent inquiry, which was triggered by the Journal Sentinel's first article about our CME activities.

The ACCME wrote that we had "implemented a careful and deliberate process to ensure that large amounts of commercial support do not in any way compromise the integrity of the university or the integrity of the continuing medical education program."

This assessment of our Office of Continuing Professional Development is consistent with other recent evaluations of our approach to identifying and managing apparent conflicts of interest.

Within the past few years, we have received public praise from the Institute on Medicine as a Profession at Columbia University and have been cited in the Journal of the American Medical Association for our leadership in managing physician conflicts of interest.

We have never rested on our laurels in this vital area. We always note the constantly changing landscape of medical education and implement cutting-edge standards of excellence. In fact, just a few days after the publication of a Journal Sentinel editorial that criticized our CME programs, the American Association of Medical Colleges cited a UW-produced CME activity that provided a comprehensive primer on swine flu as an example of "best practice" in Web-based CME.

From the very beginning, we have supported U.S. Sen. Herb Kohl's Physician Sunshine Act, legislation that would grant the public unprecedented access to information on outside activities by physicians nationwide.

If Sen. Kohl's efforts are successful, patients will be able to make their own determinations as to whether their physician's activities present a problematic conflict of interest - rather than having the news media make that judgment for them.

The UW School of Medicine and Public Health is committed to setting the standard in Wisconsin, and through the country, in transparency. For more than a century, our medical education programs have reflected the ideals of the Wisconsin Idea - we embrace a heartfelt commitment to meet the needs of the people of our state.

Journal Sentinel readers would be better served by reporting that presents the complete picture and acknowledges our successes as well as the challenges that we and our peer institutions must address.

August 12, 2009

In light of a Senate Health Education Labor and Pensions (HELP) Committee hearing on the ill-advised Medical Device Safety Act of 2009 (MDSA), Forbes Magazine published an editorial by Richard Epstein, JD with the University of Chicago of the impact this bill will have on patients and industry.

MDSA, which is now moving forward in both the House and Senate, “will overrule, retroactively for all pending cases, the Supreme Court's 2008 decision in Riegel v. Medtronic, Inc., which held that a specific statutory provision in the 1976 Medical Device Act explicitly blocked (or "expressly pre-empted" in technical jargon) state courts from allowing personal injury litigation to attack any device's design or warnings to which the FDA has given, after exhaustive inspection, its pre-market approval.”

Under the 2009 MDSA, the same type of tort suits against medical device manufacturers would be allowed against drug manufacturers.

Unlike medicines, in which patents are created to produce approved drugs that have been clinically tested, device companies face a serious obstacle: the mistakes of “downstream actors whose actions take place outside of their control. For example, while all doctors have to do is write a prescription for drugs and medicine, while noting the side effects and risks, device companies must worry about whether a physician properly uses and installs a device.

William H. Maisel, M.D., M.P.H., supported the MDSA, noting that it “will restore the consumer safeguards that are necessary to ensure the safety of medical devices for the millions of patients who enjoy their benefits.” On the other hand, Dr. Maisel did not consider how many patients will be harmed if this act passes because they will never receive the chance to try new breakthroughs and devices, such as the case of Michael G. Roman.Mr. Roman testified against the bill because of his lifelong experience from a spinal device that has helped him, as well as helping thousands of others, control their pain, and other side effects.

Dr. Maisel instead talked about the unfortunate results of an implantable defibrillator manufactured by Medtronic Sprint Fidelis. One patient who had a tragic experience with such a device, Michael Mulvihill, testified as well.

Dr. Maisel also talked about how the FDA reported that they “couldn’t find” 22% of the required post-market medical device studies for the years 1998-2000, and acknowledged that some of the studies were never started.

Interestingly, Dr. Maisel also maintained that manufacturers have an inherent financial conflict of interest, which causes the timing and extent of the product recalls to be controversial. Contrary to his belief, there are no inherent conflicts. America was founded on entrepreneurship, and free enterprise. While device companies certainly have the right to keep profits in mind, we must remember what the purpose of these companies are: to make devices to save the lives of Americans. Moreover, it is the responsibility of the government to ensure device reliability and performance, and if the FDA cannot do it, business should not suffer, nor should patients. Lastly, although there have been some technical difficulties with devices, “implanted medical devices have enriched and extended the lives of countless people.”

Professor Thomas O. McGarity also supported the legislation by asserting that “manufacturers of defectively designed or manufactured products must compensate innocent persons who have been injured by such products.”

The professor also emphasized the importance of device companies to collect data on the harm-producing potential of their products and activities in order to prevent future harm. Consequently, this recommendation was to prevent future litigation that could hurt companies more than not using such data wisely.

Ultimately, while it is the duty of the FDA to inspect devices, they are almost entirely dependent upon information submitted by medical device manufacturers at the initial approval stage. Although critics believe that this information is easily manipulated by unscrupulous companies and their consultants, there is no evidence to support these claims. The FDA is a “resource-starved federal agency that does not have sufficient personnel to keep up with ongoing technological developments, and they are generally very reluctant to revisit previous decisions in light of new information.”

Finally, Peter Barton Hutt, Esq., spoke against the legislation by acknowledging that the act, which will install rigorous standards of pre-market approval (PMA devices), will only comprise less than one-half of one percent of all the medical devices authorized by FDA for marketing since 1976. He asserted that:

The half percent of devices that are the subject of full premarket review and approval, however, represent cutting edge science. They are the new life-saving and life-sustaining devices that are critical to the public health. They are the highest priority devices -- those for which we should do everything we can to encourage investment in research and development.

Mr. Hutt emphasized that America cannot let judges and juries throughout the country to impose requirements that are inconsistent with FDA determinations, because they will differ from one Court to another, causing “regulatory chaos.” Moreover, if judges and juries can summarily disregard FDA decisions on Class III PMA devices, why should physicians, hospitals, or anyone else pay attention to them? Ultimately, the bill undermines the credibility and authority of the country’s most important public health agency.

In addition, as Justice Breyer stated during the oral argument in Warner Lambert v. Kent, “who would you rather have make the decision that this [product] is, on balance, going to save people or, on balance, is going to hurt people? An expert agency, on one hand, or 12 people pulled randomly for a jury role, who see before them only the people whom the [product] hurt and don’t see the people who need the product] to cure them?”

Instead, the solution is not to farm FDA’s work out to juries, but rather, to provide adequate funding for FDA.

Furthermore, MDSA will force manufacturers to label their products with additional or unsubstantiated warnings, which can result not only in underutilization of valuable treatments but also by confusing both physicians and their patients.

The MDSA would also remove devices approved by the FDA and would severely deter innovation. Therefore, “it is important to focus not only those who may be harmed by approved devices, but also those who are helped by those same devices, and who might be harmed if the devices were removed from the market.”

In the end, the words of a male patient who has lived a better life everyday since the use of his medical device are well put:

To me, that choice is clear. We need safe products, we need innovation, and the best way to achieve both goals is not through litigation created by this bill, but through a strong, well funded FDA.

The MDSA is not a panacea or solution to problems that may or may not arise with medical devices. Passage of this bill will have a significant negative effect on medical device innovation. Instead of punishing medical device manufacturers, of which many are small companies, for operator errors, Congress should be looking at offering pharmaceutical companies the same level of protection from unnecessary lawsuits that the device industry now receives.